Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 10000 [iU] in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-100-10 10 in 1 CARTON
1 NDC:62856-100-01 0.4 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020287 12/22/1994
FRAGMIN
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-101
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 10000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-101-10 10 in 1 CARTON
1 NDC:62856-101-01 1 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020287 12/22/1994
FRAGMIN
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-125
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 12500 [iU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-125-10 10 in 1 CARTON
1 NDC:62856-125-01 0.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020287 12/22/1994
FRAGMIN
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-150
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 15000 [iU] in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)&n |
